arznei-telegramm 2003; 34: 56


Since the introduction of the two hexavalent vaccines HEXAVAC and INFANRIX HEXA in the autumn of 2000, five children in the EU have died within 24 hours of being vaccinated. Four reports of unexplained deaths have been received from Germany and one from Austria (1). To date, around 1.6 million children have been inoculated with hexavalent vaccines in Germany. This results in an incidence of one report of unexplained death per 400,000 children. Two of the children who died were 4 or 5 months old, two were 17 months and one was 23 months old. All had been considered healthy. Suspicions that risk factors such as a family history of convulsions should be regarded as a trigger for the fatalities or that Sudden Infant Death Syndrome (SIDS) might be involved have not been substantiated (1,2). SIDS usually occurs at around 3 months of age. In 90% of cases, SIDS occurs before the age of 6 months (3).

In the case of the four German infants, cerebral oedema was found at autopsy (1). Information on clinical symptoms that preceded death is lacking from the statements published by the authorities.

The two hexavalent vaccines became notorious for side effects even when they were being licensed. Sharp increases in temperature are considered a particular problem, these temperatures exceeding 40 degrees Celsius (a-t 2001; 32: 73-4). Booster vaccinations are followed particularly frequently by temperature increases to 38 degrees Celsius and above, according to studies, for example, in 29% to 30% of cases instead of 8% to 20% after basic immunisation (3).

Despite the fatalities, the EMEA sees no grounds for a reappraisal of either vaccine (2). In our view, however, the suspicion of a link with vaccination is not ruled out. The all-clear from the authorities and their reasoning ("the great benefit far outweighs the risks" (1)) are incomprehensible to us as the same protective effect can also be achieved with vaccines of less complex composition. Until clarification is achieved, we recommend resorting to proven vaccines with fewer components.



Paul-EHRLICH-Institut: "Informationen für Ärzte und Apotheker" dated 28 April 2003;



EMEA: Public Statement of 28 April 2003



EMEA: European Public Assessment Report (EPAR) HEXAVAC, Rev. 3, 30 April 2003

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